Evivo™ with MCT Oil Now Available as Single Use Vial for Hospital Use

DAVIS, Calif., Dec. 11, 2017 /PRNewswire/ -- Evolve BioSystems, Inc. today announced a first-to-market, single-use liquid form of Evivo™ (activated B. infantis EVC001, ActiBif®). Evivo with MCT Oil, the first and only probiotic clinically proven to work with breast milk to restore a baby's gut microbiome to its natural state, is now available as single use administration for infants in a hospital setting. Research indicates that B. infantis may be both restorative and protective in the infant gut. Administering Evivo with breast milk is clinically proven to allow B. infantis to thrive and dominate the infant gut microbiome while also reducing relative populations of potentially harmful bacteria, such as E. coli, clostridia, Staphylococcus (Staph), and Streptococcus (Strep).

A healthy gut microbiome at birth paves the way for lifelong health. Modern medical practices such as C-sections, antibiotic use and formula feeding along with environmental factors in the hospital can impact the development of the infant microbiome. Research has shown that administration of probiotics to infants in the hospital is safe and effective, and may reduce the incidence of many serious, and sometimes devastating conditions. Probiotic administration has also been linked to shorter time to full feeds and may reduce incidence of sepsis.

"Safety and consistent high quality are crucial in the NICU environment," said Thomas Young, MD, neonatologist and former NICU director and Mother's Milk Bank medical director at WakeMed in Raleigh, North Carolina. "Evivo with MCT Oil, as a single-use liquid product, will be preferable to probiotics in powder form or multiuse packaging. This formulation allows for administration to term infants in the NICU and is an essential step toward properly designed clinical trials in neonates going forward."

In this formulation, Evivo's beneficial bacteria are mixed with medium chain triglyceride oil (MCT oil), providing a safe and streamlined way to deliver the probiotic to infants in a hospital setting. Evivo helps protect the baby's gut microbiome through a variety of actions derived from its ability to consume human milk oligosaccharides (HMOs). The beneficial bacteria in Evivo are able to utilize the HMOs in breast milk in a unique and superior manner compared to other gut bacteria, and convert HMOs into nutrients that nourish both the infant and the gut microbiome. The bacteria in Evivo have been shown to be anti-inflammatory, to decrease intestinal permeability, and increase the production of lactate and acetate, which can suppress the growth of potentially harmful bacteria. Furthermore, Evivo given daily to breastfed infants was shown to result in significantly fewer loose and watery stools per day, without an increase in incidence of jaundice or other adverse events.

"Increasing the levels of beneficial bacteria while decreasing levels of potentially harmful bacteria could play a significant role in mitigating some of the most common risks these vulnerable babies face in the NICU," said David Kyle, PhD, chief scientific officer of Evolve BioSystems. "Evivo reprograms the infant gut microbiome and helps babies utilize the full nutritional value of human milk, which supports the ultimate goal of healthy weight gain and getting them home with their families."

Evolve BioSystems' landmark clinical trial, recently published in the American Society for Microbiology journal mSphere, showed that providing dietary B. infantis EVC001 resulted in rapid, substantial, and persistent remodeling of the gut microbiome in breastfed infants. This stable colonization of B. infantis EVC001 led to significant reduction in the abundance of potentially harmful bacteria. In addition, this improved gut profile persisted for more than 30 days after dietary B. infantis was discontinued, as long as infants continued to consume breast milk.

About Evolve BioSystemsEvolve BioSystems, Inc. is a privately-held microbiome company dedicated to developing the next generation of products to establish, restore, and maintain a healthy gut microbiome. Evolve is a spin-out from the Foods for Health Institute (FFHI) at the University of California, Davis and builds on more than a decade of research into understanding the unique partnership of the infant gut microbiome and breast milk components. Having led to the development and commercial launch of products to resolve newborn gut dysbiosis, including Evivo™ for infants and GlycoGuard® for nursing foals, Evolve's discovery platform is now being applied to solving gut dysbiosis throughout the human life cycle as well as other animal species. In addition to the landmark proof-of-concept IMPRINT trial, Evolve is undertaking further clinical studies to build out its suite of microbiome-based solutions.

For more information or to purchase Evivo, please visit www.evivo.com.